COVID-19 Therapeutics Transition to Commercial Distribution: Frequently Asked Questions

The enrollment process for the Patent Assistance Programs operated by Pfizer (Paxlovid) and Merck (Lagevrio) are designed to be easy for patients and providers with minimal input requirements.

For the Paxlovid USG PAP operated by Pfizer and the Pfizer Co-pay Savings program, enrollment can be completed over the phone or through the PAXCESS Paxlovid portal by the patient, a caregiver, a healthcare provider, or the pharmacist at the point of care. To enroll, the person completing the application must provide both patient and prescribing health care provider information, and the application will confirm the patient's insurance status; there are no income eligibility requirements. Upon enrollment, which is anticipated to take approximately 5 minutes, the patient is provided an electronic voucher that can be exchanged for a free Paxlovid treatment course at participating pharmacies. Overnight shipping to the patient's home also will be available, which may be useful for patients seeking to fill the Paxlovid prescription at a pharmacy not participating in the USG PAP operated by Pfizer or a pharmacy without Paxlovid inventory. We anticipate additional mechanisms for Medicaid and some Medicare beneficiaries to receive free USG Paxlovid without the need to enroll to become available starting in January.

For Lagevrio, the Merck PAP (a 501c3 non-profit organization) anticipates the time to determine if a patient is eligible for the program to be 10 to 20 minutes.

Yes. The transition on November 10, 2023 for Lagevrio and December 15, 2023 for Paxlovid did not change the ability of certain federal entity partners, including HRSA-supported health centers, to order free USG-acquired product. Please refer to the Therapeutics Transition Guide for additional details. State health officials will continue to have visibility into sites within their jurisdiction that continue to order USG-procured supply.

Federal law does not require commercial plans to cover all possible COVID-19 treatments or put any limits on patient cost-sharing for any commercial plans if the treatments are covered. Plans generally have discretion to cover medicines under Emergency Use Authorization and to set cost-sharing rules for them as they do for FDA-approved drugs. Commercial plans in the individual and small group markets must offer some antiviral coverage, although not all antivirals may be covered. In such a case, enrollees may request access to non-formulary drugs through an exceptions process, including on an expedited basis.

There are programs intended to ensure continued access to COVID-19 oral antivirals for individuals covered by commercial insurers. These include the Pfizer Co-pay Savings Program for Paxlovid, the MerckHelps Patient Assistance Program for Lagevrio, and the continued distribution of USG-procured supply of both oral antivirals to certain federal entities, such as HRSA-funded health centers and IHS health centers.

Like other dispensing sites, Test to Treat locations that are owned by private companies will use the USG-purchased product they have in stock and then purchase the oral antivirals through traditional commercial channels once their USG supply is depleted or is no longer usable. The patient assistance and co-pay programs can be leveraged at these locations, as they can elsewhere, to provide the oral antivirals at little-to-no cost to eligible patients.

Some Test to Treat locations that are federally-supported, such as HRSA-supported health centers, can continue to leverage the HHS supply of Lagevrio and Paxlovid.

• Pfizer is currently working with their program vendor to discuss participation in the USG PAP operated by Pfizer with many of the retail pharmacies across the United States.
• Retail pharmacies can learn more about participating in the USG PAP operated by Pfizer by contacting the program vendor at PharmacyNetworkContract102101@assistrx.com.
• Pharmacies that are participating in the USG PAP operated by Pfizer will be paid a dispensing fee upon adjudication of the USG PAP operated by Pfizer voucher.

Commercial ordering for the two COVID-19 oral antivirals, Paxlovid and Lagevrio, opened on November 1, 2023. Provider sites can use their usual mechanisms to place commercial orders as product moves to wholesalers. Both Paxlovid and Lagevrio are available from multiple wholesalers, although specific timelines for availability may vary.

For Paxlovid, FDA has updated the EUA indicating the EUA-labeled Paxlovid will no longer be authorized for emergency use after March 8, 2024, regardless of the labeled or extended expiration date. Providers with USG-distributed, EUA-labeled Paxlovid are encouraged to return product expiring December 2023 or later through the Pfizer returns process by February 29, 2024. All returns should be initiated by mid-February to ensure product is received by February 29, 2024, to be accepted for credit to the federal inventory. Returned USG-purchased Paxlovid will be used to support access to free Paxlovid for publicly insured patients, including Medicare and Medicaid beneficiaries, and uninsured patients through the USG PAP operated by Pfizer. Eligible patients can enroll online.

To ensure maximum value of the USG-purchased inventory, sites are encouraged to return EUA-labeled Paxlovid. Pfizer will refresh the USG-purchased supply through 2028, ensuring that the USG inventory of Paxlovid is not expired and that it includes new formulations of Paxlovid authorized or approved for use in the United States. Providers should maximize use of the USG-distributed supply, particularly to ensure distribution channels, payment systems, and the USG PAP operated by Pfizer are fully operational before returning EUA-labeled Paxlovid. FDA has updated the EUA indicating the EUA-labeled Paxlovid will no longer be authorized for emergency use after March 8, 2024, regardless of the labeled or extended expiration date.

For Lagevrio, dispensing sites should use the USG-purchased supply in their inventory through its depletion or until expiry, whichever comes first.

For both treatments, the USG-distributed supply can continue to be leveraged for any eligible patient so long as the individual EUAs are still active, and the product is not expired. Any of the government-purchased supply that sites dispense must remain available to patients for free.

Lagevrio: Lagevrio is not currently eligible for return as none of the USG-distributed Lagevrio has reached expiration; current expiration dates are February 2024—February 2025. We are not aware of any upcoming shelf-life extensions for Lagevrio.

Paxlovid: Any expired product, once current expiration date is confirmed, should be returned as soon as expiration is reached. After March 8, when EUA-labeled product will no longer be authorized for use, all EUA-labeled Paxlovid, regardless of expiration date, must be disposed.

In addition, Paxlovid with an expiry of December 2023 or later (including non-expired Paxlovid) can be returned by February 29, 2024, for USG to receive a replacement credit to its inventory that supports the USG PAP operated by Pfizer. All returns should be initiated by mid February, to ensure product is received by February 29, 2024, to be accepted for credit to the federal inventory. In some cases, costs associated with return shipping may be covered. For all Paxlovid returns, Visit Inmar, email PaxlovidEUAreturns@inmar.com or call 877-740-6148.

This question is directly addressed in the FDA Frequently Asked Questions on the Emergency Use Authorization for Paxlovid for Treatment. As part of that response, please note the clarification that the EUA does not place any limitation on the presentation of Paxlovid to be dispensed (EUA-labeled Paxlovid or NDA-labeled Paxlovid) when pharmacist prescribing is consistent with the conditions in the EUA letter of authorization. This means that pharmacists can prescribe either NDA-labeled or EUA-labeled Paxlovid within those conditions. The letter of authorization also enables the use of NDA-labeled Paxlovid for patients ages 12 to 17 when prescribed under the conditions of the EUA.

USG has developed a mechanism for providers to report commercial treatment location data voluntarily that is now visible in an expanded Treatments Locator tool. As of November 27, sites can voluntarily upload commercially acquired inventory data for Paxlovid, Lagevrio, and outpatient Veklury via HPOP. HPOP users can leverage their existing accounts to report, while non-HPOP users can report using the HPOP volunteer reporting website. Separately, USG distributed product should continue to be entered in the appropriate HPOP reporting fields. USG product should continue to be entered in the appropriate HPOP reporting fields.

We ask that dispensing locations continue to provide information on where oral antivirals are located to enable everyone eligible to find the medicines they need.

Paxlovid is eligible for 340B pricing, if it is for commercial use, as a covered outpatient drug as defined at section 1927(k)(2) of the Social Security Act.

Lagevrio has an EUA and is not eligible for 340B pricing as it is not a covered outpatient drug as defined at section 1927(k)(2) of the Social Security Act.

For Medicare beneficiaries enrolled in a Part D plan, COVID-19 oral antivirals must be covered by the plan, but cost-sharing or other plan coverage rules (like requesting a formulary exception) may apply. People who do not have a Part D plan or who might otherwise face cost-sharing or coverage restrictions can access Paxlovid for free through the Paxlovid USG PAP operated by Pfizer.

Any pharmacy may fill prescriptions for COVID-19 oral antivirals. Patients should check with their insurance plan and pharmacy to make sure they do not face excess charges. Enrollment in the Paxlovid USG PAP operated by Pfizer ensures zero cost for those eligible, including all Medicare beneficiaries. Some Medicare Part D plans may be participating in the Paxlovid USG PAP operated by Pfizer for no-cost access without patients needing to enroll or take additional action. If patients are presented with an out-of-pocket cost for Paxlovid, patients may still choose to enroll to reduce cost to zero. In some cases, their pharmacy may be able to assist with enrollment.

People with Medicaid coverage can obtain the product from pharmacies using a streamlined process through each state's Medicaid Drug Rebate Program (MDRP). The Paxlovid USG PAP operated by Pfizer is always available for anyone eligible who would otherwise face a cost to obtain Paxlovid. For Medicaid fee-for-service (FFS) programs, Pfizer will calculate a state-specific Unit Rebate Amount (URA) for each state using the "Medicaid paid amount" (including professional dispensing fees) divided by the number of units invoiced for that state. This state-specific URA will then be used to reimburse units invoiced for the states' FFS programs.

The availability of Paxlovid though the PAP does not change the requirement that Medicare Part D plans must cover Paxlovid through the formulary or through a formulary exception, if requested. Medicare Part D plans that contract with Pfizer to facilitate the PAP will add Paxlovid to their formulary and process claims with $0 cost-sharing, eliminating the need for the beneficiary to enroll separately in the Paxlovid USG PAP operated by Pfizer. Paxlovid claims paid by the Part D plan—either by facilitating the Paxlovid USG PAP operated by Pfizer or providing coverage through the plan benefit—will pay a dispensing fee according to the plan and pharmacy's contract terms. If a Part D plan is not contracted with Pfizer to facilitate the Paxlovid USG PAP operated by Pfizer, claims for commercial Paxlovid that is not USG-procured will be processed by the plan according to the plan's formulary and coverage rules. In all cases, Medicare beneficiaries, whether they have Part D coverage or not, can enroll in the USG PAP operated by Pfizer access no-cost Paxlovid.

Under the American Rescue Plan (ARP), Medicaid plans must cover COVID-19 oral antivirals until the end of the third quarter of calendar year 2024. Medicaid beneficiaries are also eligible for no-cost Paxlovid through the Paxlovid USG PAP operated by Pfizer. HHS has developed a streamlined process using the state's Medicaid Drug Rebate Program (MDRP) to assist states during this transition period.

People with Medicaid coverage can obtain Paxlovid from pharmacies using a streamlined process through each state's MDRP. The Paxlovid USG PAP operated by Pfizer is always available for anyone eligible who would otherwise face a cost to obtain Paxlovid. For Medicaid fee-for-service (FFS) programs, Pfizer will calculate a state-specific Unit Rebate Amount (URA) for each state using the "Medicaid paid amount" (including professional dispensing fees) divided by the number of units invoiced for that state. This state-specific URA will then be used to reimburse units invoiced for the states' FFS programs.